Earlier this month, FDA took the system offline after discovering a security vulnerability. Because of this, the Agency has announced that the compliance date for “non-class III implantable, life-supporting and life-sustaining medical devices” will be extended from September 24, 2015 to October 24, 2015 (see full guidance here).
We can help ensure your device and company is compliant with FDA regulations! Our unique approach, which combines a deep scientific knowledge with extensive regulatory expertise, has helped a number of our clients ensure compliance and get through FDA successfully. For more information on how we can help you, please contact us.
FDA Holds Public Workshops to Discuss Regulatory Strategies for Next Generation Sequencing Diagnostics, Part 1
As we discussed in a previous FDA News article, the Agency is in the midst of developing “novel ways to optimize its regulation of Next Generation Sequencing (NGS) tests.” The Agency’s ultimate goal...